Posted by Michael Wonder on 20 Aug 2020
Precision BioSciences receives fast track disease designation from U.S. FDA for PBCAR0191 investigational allogeneic CAR T-cell therapy
19 August 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to Precision for PBCAR0191, the company’s lead investigational allogeneic chimeric antigen receptor cell therapy for the treatment of advanced B-cell precursor acute lymphoblastic leukaemia.
PBCAR0191 is being evaluated in a Phase 1/2a multicenter, non-randomised, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and tolerability of PBCAR0191 in adult patients with relapsed/refractory B-cell acute lymphoblastic leukaemia and relapsed/refractory non-Hodgkin's lymphoma.
